83504-153-10 |
83504-153 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20240101 |
N/A |
NDA |
NDA021164 |
Fabre Kramer Pharmaceuticals, Inc. |
GEPIRONE HYDROCHLORIDE |
72.6 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-153-10) |
83504-152-10 |
83504-152 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20240101 |
N/A |
NDA |
NDA021164 |
Fabre Kramer Pharmaceuticals, Inc. |
GEPIRONE HYDROCHLORIDE |
54.5 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-152-10) |
83504-151-10 |
83504-151 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20240101 |
N/A |
NDA |
NDA021164 |
Fabre Kramer Pharmaceuticals, Inc. |
GEPIRONE HYDROCHLORIDE |
36.3 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-151-10) |
83504-150-10 |
83504-150 |
HUMAN PRESCRIPTION DRUG |
EXXUA |
gepirone |
TABLET, EXTENDED RELEASE |
ORAL |
20240101 |
N/A |
NDA |
NDA021164 |
Fabre Kramer Pharmaceuticals, Inc. |
GEPIRONE HYDROCHLORIDE |
18.2 mg/1 |
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-150-10) |